UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002531 |
|---|---|
| Receipt number | R000003091 |
| Scientific Title | Combination Therapy of Angiotensin II Receptor Blocker and Calcium Channel Blocker Exerts Pleiotropic Therapeutic Effects in Addition to Blood Pressure Lowering |
| Date of disclosure of the study information | 2009/09/18 |
| Last modified on | 2015/09/19 09:45:00 |
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Basic information
Public title
Combination Therapy of Angiotensin II Receptor Blocker and Calcium Channel Blocker Exerts Pleiotropic Therapeutic Effects in Addition to Blood Pressure Lowering
Acronym
Combination Therapy of Angiotensin II Receptor Blocker and Calcium Channel Blocker Exerts Pleiotropic Therapeutic Effects in Addition to Blood Pressure Lowering
Scientific Title
Combination Therapy of Angiotensin II Receptor Blocker and Calcium Channel Blocker Exerts Pleiotropic Therapeutic Effects in Addition to Blood Pressure Lowering
Scientific Title:Acronym
Combination Therapy of Angiotensin II Receptor Blocker and Calcium Channel Blocker Exerts Pleiotropic Therapeutic Effects in Addition to Blood Pressure Lowering
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to examine beneficial effects of combination therapy with candesartan and amlodipine on BP control and markers of target organ function in Japanese essential hypertensive patients who did not achieve the target BP level during the monotherapy period either by candesartan or amlodipine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
A. Clinic blood pressure
B. Home blood pressure profile
C. Renal function including eGFR and urinary protein/albumin excretion.
D. Vascular function including central BP, AI, baPWV and ABI.
Key secondary outcomes
1. Glucose metabolism including FPG, IRI, HOMA-IR, HbA1C.
2. Lipid metabolism including T-cho, LDL-cho, HDL-cho, and TG.
3. Activity of sympathetic nerve and renin-angiotensinsystem including PRA, PAC, catecholamine, and urinary angiotensinogen.
4. Oxidative stress marlers including pentosidine and urinary L-FABP.
5. Cardiac function including BNP, cardiac echographic parameters.
6. CBC, electrolyte, and liver function.
7. Adverse events.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
This study consisted of a 4-week mono therapy period and 12-week combination therapy period. The patients already being treated with amlodipine, a once-daily 8 mg dose of candesartan was added-on during the combination therapy period, and a once-daily 5 mg dose of amlodipine was added-on for those already being treated with candesartan.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The eligible subjects were mild-to-moderate essential hypertensive patients who were already treated with a once-daily 5 mg dose of amlodipine monotherapy or with a once-daily 8 mg dose of candesartan monotherapy at the initiation of the monotherapy period and did not achieve the target BP level according to the Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH2009) during the monotherapy period .
Key exclusion criteria
Exclusion criteria included patients who exhibited severe hypertension (clinic systolic >= 180 mmHg and/or diastolic BP >= 110 mmHg), renal insufficiency (estimated glomerular filtration < 30 ml/min/1.73 m2), women who were nursing or pregnant, clinically significant heart disease, moderate-to-severe hepatic dysfunction, and known hypersensitivity to any component of the study medications.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouichi TAMURA |
Organization
Yokohama City University School of Medicine
Division name
Dapartment of Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL
045-787-2635
tamukou@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kouichi TAMURA |
Organization
Yokohama City University School of Medicine
Division name
Dapartment of Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL
045-787-2635
Homepage URL
tamukou@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
横浜市立大学附属病院
Yokohama City University Hospital
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 09 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 09 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 18 | Day |
Last modified on
| 2015 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003091
